FDA authorizes On/Go One™, the most accurate, compact, and affordable rapid COVID-19 antigen test that can help transition COVID-19 from pandemic to endemic
The new antigen test delivers results with 98.2% accuracy in 15 minutes and detects all major known variants, including Omicron, with just one easy-to-use test.
MIAMI, March 2, 2022 /PRNewswire/ -- Intrivo, a U.S.-based health-tech leader, announced today the launch of On/Go One™, a rapid COVID-19 test which recently gained Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). The new antigen test delivers results with 98.2% accuracy in 15 minutes and detects all major known variants, including Omicron, with just one easy-to-use test. On/Go One is available today on Amazon and at LetsOnGo.com for rapid delivery direct to consumers' homes.
On/Go One harnesses Intrivo's years of experience fighting COVID to offer clear advantages over existing rapid tests, including:
- One single test to detect COVID-19 status
- A compact and convenient form factor
- A 12-month shelf life
- Top rated user experience (4.9 stars on iOS, 4.6 stars on Google)
- Affordable price ($9 MSRP), covered by insurance
"On/Go One represents the next frontier in Intrivo's mission to help all Americans everywhere live happier, healthier, safer lives by helping to detect and control current and future variants and finally making the pandemic endemic once and for all," said Ron Gutman, co-CEO of Intrivo. "The team at Intrivo has brought all the experience we've accumulated over the past couple of years supplying millions and millions of tests to everyone from Government to schools, and from large enterprises to individual consumers, to create an all-in-one solution empowering everyone to go on the offense against COVID-19. For the first time, we can all act proactively to stay ahead of the virus and prevent the next outbreak. Our all new On/Go One test is potent enough to detect COVID-19 with a single, rapid test (unlike competitive products that typically require two tests), and was developed and FDA-authorized with our top-rated On/Go companion app and underlying technology, enabling ease of use for consumers and real-time data and insights for population health managers and governments. Together, we can now detect the emergence and spread of a potential new outbreak when it starts to emerge before it's too late to respond locally and avoid the consequences we've experienced in past waves."
The new test joins Intrivo's innovative suite of products to help Americans as they navigate their entire COVID-19 journey, from testing to care. First, the free On/Go companion mobile app makes the testing process easy by guiding users through each step and providing timers and guidance when necessary. In the event of a positive result, users are directed to an Advanced Care Toolkit (ACT), which includes access to a team of Care Guides, who are specifically trained to provide non-medical support and guidance on next steps. For medical assistance, On/Go has partnered with UnitedHealthcare's Optum to provide immediate access to same-day virtual appointments with a trained medical provider. Taken together, On/Go offers the most comprehensive solution to managing COVID-19 with an all-in-one, easy, affordable and accessible solution.
"My family and I are always on the go," Intrivo co-CEO Reeve Benaron said. "On/Go One's portability, affordability and long shelf life make it easy and convenient for any family to keep at home, or take with them whenever needed. Having recently experienced COVID in our family, we're planning to keep On/Go One tests everywhere – from our bathroom cabinet, to our suitcases that are ready for our next vacation, and from our cars, to our home-office – so, no matter where we are, we will always be safe and protected."
To learn more about On/Go One, visit https://www.letsongo.com/
*A clinical validation study of the On/Go One test kit found that, when compared to the results of an RT-PCR molecular test, it was able to detect 93% of positive samples and 100% of negative samples. It has been cleared for self-testing by patients ages 14 and older and for administration by an adult to children as young as 2 years old.
About Intrivo
Intrivo is a leading health-tech company harnessing the power of AI and user-centered design to help control COVID-19 while preparing the world to tackle the next health challenges and helping everyone live happier, healthier and safer lives.
Intrivo's On/Go kits combine testing and technology to offer a trusted, comprehensive solution for consumers and enterprises alike to stay ahead of COVID-19. On/Go products can be ordered directly at letsongo.com, or via our iOS and Android apps.
In the past year, Intrivo has served customers including federal and state governments, large employers, healthcare systems, leading retailers, entertainment venues and cruise lines, as well as families and individuals everywhere. Intrivo has delivered tens of millions of FDA-authorized COVID-19 tests worldwide, achieved multiple FDA and other authorizations across a variety of markets, all while leveraging its superior patent-pending technology to help population health managers and millions of users gain true peace of mind. While the company is currently focused on the global COVID-19 pandemic, it is actively expanding its solutions to make healthcare more accessible and affordable for both consumers and enterprises. To learn more about Intrivo and its world-class, tech-driven solutions, please visit www.intrivo.com.
The On/Go One™ COVID-19 Antigen Home Test has not been FDA cleared or approved but has been authorized by the FDA under an Emergency Use Authorization (EUA). This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens, and is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
Media Contact:
Jessica Savarese
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SOURCE Intrivo
